Quality Systems

Articles

The company is recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) because of nitrosamine impurities.

Nostrum Laboratories Expands Recall of Metformin HCl Extended Release Tablets

Feliza Mirasol is the science editor for 

Traditional biologic-based testing methods may need an upgrade to properly test newer therapeutic modalities.

Meeting Specificity Needs for Biologic Drug Substance Testing

Editor of Pharmaceutical Technology Europe

EMA’s SPOR implementation guide version two is expected to be published soon, starting the countdown for companies to ensure their data-based submissions are compliant.

Coming Up to ISO IDMP Standards

Positive regulatory developments are aiding the growth of the cannabis pharmaceuticals market, but more clinical data are needed to break the stigma and bring science to the fore.

The Budding Field of Cannabis Pharmaceuticals

FDA sent a warning letter to Clientele for CGMP violations at the company’s Sunrise, FL facility that included a lack of an adequate quality unit.

Florida Company Receives FDA Warning Letter

Sunstar Americas is expanding its voluntary recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products because of Burkholderia lata contamination.

Recall of Paroex Oral Rinse Expanded

The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System is the first in a four-part series that will address refining pharmaceutical quality and guaranteeing sustainable compliance within organizations.

ISPE Releases First Guide from its Advancing Pharmaceutical Quality Program

Will Kanyi is Senior Training Specialist at Catalent Biologics.

Alternative approaches to training design can better address the desired performance outcomes in a GMP environment while delivering relevant information to meet regulatory compliance.

Compliance vs. Competency: Designing CGMP Training with Performance Outcomes in Mind

The Vaccines Manufacturing and Innovation Centre (VMIC) has chosen Lonza’s MODA-EM solution for the digitalization of its microbiology quality control operations.

VMIC Adopts Lonza’s Paperless Quality Control Microbiology Platform

The product is being recalled because of Burkholderia cepecia contamination.

Quality Assurance/Quality Control